BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1961446 · Received January 7, 2011

    Report

    Report Number
    2023826-2011-00020
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 30, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P9800048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE HAPTIC OF AN AQ2015A SILICONE ASPHERIC THREE PIECE LENS BROKE WHEN THE TECH ATTEMPTED TO LOAD THE LENS INTO THE CARTRIDGE. THERE WAS PATIENT CONTACT BUT NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR CARTRIDGE: MODEL AQ CARTRIDGE-FP, LOT# 1258961| INJECTOR: MODEL MSI-PM, LOT NUMBER: UNK